SINGLE VIAL LDH-L TRIS— 510(k) K781538

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K781538 for SINGLE VIAL LDH-L TRIS, Substantially Equivalent on 1978-10-03. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant
Boehringer Mannheim Corp.
Product code
Code CFJ
Device class
Class 2
Regulation
21 CFR 862.1440
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
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